Dossier Processing and Lifecycle Managemente.g. processing of marketing approvals (planning and submittal of variations, renewals); preparation of dossiers for variations, expert opinions for renewals (quality, non-clinical and clinical expert statements; addendum to the quality, non-clinical and clinical overview) and ex ante expert opinions (AMG); transformation from NtA to CTD, and from CTD to eCTD; processing of deficiency notices (quality, non-clinic, clinic); submittal of documentation to the licensing authorities...

Scientific Expert Opinionse.g. toxicological expert opinions, scientific expert opinions for questions related to quality, non-clinic and clinic for use in R&D, medicinal product development and marketing authorisation (e.g. within the scope of deficiency notices) hazardous substance classification according to the ordinance on hazardous substances...

Medical Writinge.g. preparation of publications, study protocols and final reports of clinical and non-clinical studies...